NCT06295770招募中2 期
A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab
研究概览
简要总结
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Biopsy proven fibrillary glomerulonephritis
- •Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy
- •eGFR ≥ 20 ml/min/BSA
排除标准
- •Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy)
- •Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy)
- •Hepatitis B, C or HIV positive
- •Pregnant or breast-feeding
- •Active infection
- •Kidney transplant
- •Anemia with Hgb < 8.0 g/dL
- •Thrombocytopenia with platelet count < 100'000
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
- •Patients who have received cyclophosphamide in the last 6 months
- •Patients who have received ACTH and/or mycophenolate mofetil in the last 30 days
- •Patient who are on prednisone therapy at a dose > 10 mg/day in the last 15 days
- •Patients who received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment
- •For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
- •For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug
研究组 & 干预措施
Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Experimental
Patients with biopsy proven fibrillary GN who have >1 gram/24 hour of proteinuria and eGFR ≥ 20 ml/min/BSA will be treated with Obinutuzumab.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab
时间窗: Baseline, 6 months, 12 months
Measured using 24-hour urine collection reported in mg/24h
次要结局
- Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab(Baseline, 6 months)
- Rate of complete or partial remission(6 months, 12 months)
- Improvement in serum albumin(Baseline, 6 months, 12 months)
- Stabilization of kidney function(Baseline, 6 months, 12 months)
- Serious Adverse Events (SAEs)(Day 1-12 months)
研究者
研究点 (1)
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